Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.

Study Overview

• Status: Completed
• Conditions: Acute Compartment Syndrome
• Intervention / Treatment: Behavioral: Muscle contraction

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens Orthopedic Clinic, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study sample will consist of healthy volunteers recruited from the principle investigator's private practice.

Description

Inclusion Criteria:

• 18-75 years old
• no current extremity injuries
• willing to provide written informed consent

Exclusion Criteria:

• history of any anatomy-altering surgery to the extremity in question
• history of peripheral vascular disease
• history of pulmonary disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exercise; NIRS values of all participants will be measured at baseline and following each 30-60 second exercise.	Behavioral: Muscle contraction; Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near infrared spectroscopy	NIRS values will be measured before and after muscle fatigue	<30 minutes

Collaborators and Investigators

• Sponsor: J&M Shuler

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: near-infrared spectroscopy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes
• Other Study ID Numbers: NIRS-01